Cancer is a class of diseases characterized by out-of-control cell growth. There are more than 100 different types of cancer, and each is classified by the type of cell that is initially affected. A list of potential cancers that may be treated using one or more varieties of treatment (e.g., surgery, radiation, chemotherapy, immunotherapy, hormone therapy, gene therapy or combination therapies) includes cancer of bodily organs or tissues such as breast, prostate, kidney, brain, mouth, esophagus, stomach, intestine, colon, rectum, pancreas, bladder, uterus, cervix, ovary, vagina, testicle, liver and lung, as well as cancers of the circulatory system including leukemia and lymphoma, and skin cancers including basal cell and melanoma.
Cancer harms the body when altered cells divide uncontrollably to form tumors (except in the case of leukemia where cancer prohibits normal blood function by abnormal cell division in the blood stream). Tumors can grow and interfere with the digestive, nervous, and circulatory systems and they can release hormones that alter body function. Tumors that stay in one spot and demonstrate limited growth are generally considered to be benign. Malignant tumors form when one of the following occurs: a.) a cancerous cell manages to move throughout the body using the blood or lymphatic systems, destroying healthy tissue in a process called invasion, or b.) a cancerous cell begins to divide and grow, creating new blood vessels to feed itself in a process called angiogenesis. When a tumor successfully spreads to other parts of the body and grows, invading and destroying other healthy tissues, it is said to have metastasized and the condition becomes much more difficult to treat.
Cancer is considered to be one of the leading causes of morbidity and mortality worldwide. According to the American Cancer Society, cancer is the second most common cause of death in the US and accounts for nearly 1 of every 4 deaths. The World Health Organisation (WHO) estimates that, worldwide, there were 4 million new cancer cases and 8.2 million cancer-related deaths in 2012. In the US more than 575,000 people die of cancer, and more than 1.5 million people are diagnosed with cancer per year. According to WHO, the numbers of new cancer cases is expected to rise by about 70% over the next 20 years. The financial costs of cancer in the US per year are an estimated $263.8 billion in medical costs and lost productivity.
There continues to be an exceptionally high interest in developing safer and more efficacious anti-carcinoma drugs, in large part due to the growing awareness (e.g., early detection of breast and colon cancers) of the impact of cancer on patients and families, productivity and healthcare costs as portrayed in the media and through advocacy groups including the American Cancer society. Pharmaceutical and biotech companies continue to allocate significant resources to the discovery of effective, better tolerated and potentially more affordable treatments. In the ten-year period 2005-2014, the FDA approved a total of 84 new medications, with a high of 18 in 2012 (https://www.centerwatch.com/drug-information/fda-approved-drugs/therapeutic-area/12/oncology).
The present invention relates to the use of novel cycloalkyl-diamines and their pharmaceutical compositions for the treatment of cancer in mammals, including humans, and may provide a benefit with respect to efficacy or toleration in comparison to currently available chemo-therapeutic agents.